Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Harvard Business School
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Last Updated: December 14, 2019

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BREO ELLIPTA Drug Profile

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Which patents cover Breo Ellipta, and what generic alternatives are available?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are fourteen patents protecting this drug.

This drug has three hundred and eighty-two patent family members in forty-two countries.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.

US ANDA Litigation and Generic Entry Outlook for Breo Ellipta

Breo Ellipta was eligible for patent challenges on May 10th, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 21st, 2025. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $1.7bn, indicating a strong incentive for generic entry.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

Drug patent expirations by year for BREO ELLIPTA
Drug Prices for BREO ELLIPTA

See drug prices for BREO ELLIPTA

Drug Sales Revenue Trends for BREO ELLIPTA

See drug sales revenues for BREO ELLIPTA

Generic Entry Opportunity Date for BREO ELLIPTA
Generic Entry Date for BREO ELLIPTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BREO ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ParexelPhase 2
AstraZenecaPhase 2
ParexelPhase 4

See all BREO ELLIPTA clinical trials

Recent Litigation for BREO ELLIPTA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-08
GlaxoSmithKline Intellectual Property Management Limited v. Sandoz Inc.

See all BREO ELLIPTA litigation

US Patents and Regulatory Information for BREO ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BREO ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013   Start Trial   Start Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for BREO ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1425001 CA 2014 00021 Denmark   Start Trial PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
1425001 1490033-6 Sweden   Start Trial PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113
1425001 14C0028 France   Start Trial PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.